Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy

NCT04582591 | Unknown Phase 2 DMC

• 1 other identifier: REG-114-2020
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

CIPN; Cannabinoid; Cannabidiol; CBD; Neurotoxic Chemotherapy; paclitaxel; oxaliplatin; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• Difference in Acute Neuropathic Symptoms from baseline and during 1. course chemotherapy.

  Difference in the North Central Cancer Treatment Group (NCCTG)- acute-CIPN Questionnaire from baseline compared to 3-5 days after initiation of chemotherapy course no. 1. The Questionnaire contains single items questions, answerable on a 0-10 numeric scale, 0 corresponds to no symptoms and 10 worst possible symptoms.

  up to 5 days

• Difference in Vibrograms from baseline and during 1. course chemotherapy.

  Difference in the Vibrograms from baseline compared to 3-5 days after initiation of chemotherapy course no. 1.

  up to 5 days

Secondary Outcomes (17)

• Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 6th course of chemotherapy or the last course of chemotherapy (if before course no. 6).

  through study completion, an average of 1 year and 6 months

• Difference in baseline vibrograms of patients treated with CBD compared to vibrograms at follow-up 3 mo. after the end of the 4th course of chemotherapy or the last course of chemotherapy (if before course no. 4)

  through study completion, an average of 1 year and 6 months

• Difference in CIPN from baseline to after chemotherapy course no. 3

  through study completion, an average of 1 year and 6 months

• Difference in CIPN from baseline to after chemotherapy course no. 6

  through study completion, an average of 1 year and 6 months

• Difference in CIPN from baseline to 1. follow-up (PAC)

  through study completion, an average of 1 year and 9 months

Other Outcomes (6)

• Side Effects (Clinician Scored)

  through study completion, an average of 1 year and 6 months

• Side Effects (Patient Reported)

  through study completion, an average of 1 year and 6 months

• Change in vibrograms at day 3-5 from baseline compared to overall CIPN18 score at 3 months (PAC)

  through study completion, an average of 9 months

Study Arms (1)

Cannabidiol

EXPERIMENTAL

Patients will receive cannabidiol in conjunction with their standard chemotherapy treatment

Drug: Cannabidiol 100 MG/ML

Interventions

Cannabidiol 100 MG/ML DRUG

Patients receive cannabidiol before and after treatment with chemotherapy

Also known as: CBD

Cannabidiol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• A diagnosis of cancer.
• Fulfill criteria for starting chemotherapy.
• Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.
• If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG\*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).

You may not qualify if:

• Unable to complete PRO-measurements.
• Previously received taxanes or platinum-based chemotherapy.
• Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)
• Baseline transaminase level must not be above 3 times the Upper Limit of Normal (ULN) at study beginning.
• Women who are breastfeeding.
• Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.
• CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.

Sponsors & Collaborators

• Zealand University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Department of Clinical Oncology and Palliative Care

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jørn Herrstedt, DMSc

  Zealand University Hospital / University of Copenhagen

  STUDY CHAIR

• Sebastian W Nielsen, MD

  Zealand University Hospital / University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 9, 2020
• Study Start: March 3, 2021
• Primary Completion: January 5, 2022
• Study Completion: August 30, 2023
• Last Updated: February 8, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)